1. Field of the Disclosure
The present disclosure relates in general to pharmaceutical compositions, and more specifically to a transdermal composition and methods to treat plantar fasciitis.
2. Background Information
Plantar fasciitis is a painful inflammatory process of the plantar fascia, the connective tissue on the sole (bottom surface) of the foot. It may be often caused by overuse of the plantar fascia or arch tendon of the foot. Plantar fasciitis may be a very common condition and may be difficult to treat if not looked after properly. An incidental finding associated with this condition may be a heel spur, a small bony calcification on the calcaneus heel bone, in which case it is the underlying plantar fasciitis that may produce the pain, and not the spur itself. The condition is responsible for the creation of the spur; the plantar fasciitis is not caused by the spur.
Typical treatments for plantar fasciitis may include indications to get rest and avoid the use of the foot in pain, the use of orthotics or boots, administering of low doses of drugs directed to treatment of the symptoms experienced by the individual patient, such as oral anti-inflammatories or injections of corticosteroids; and invasive surgery, among other treatments. These types of treatments may involve applying the drug, therapy, or surgery where the pain is located; nevertheless, the percentage of effectiveness of a surgery is from about 30% to about 60%. Additionally, there may be a high number of cases of plantar fasciitis that may be misdiagnosed and may be actually myofascial trigger points, or may be using a treatment that may not be as effective as it is needed.
Local anesthetics may block the generation and conduction of nerve impulses by increasing the threshold for electrical excitation in the appropriate nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. Local anesthetics may be extremely potent and may result in a virtually complete loss of sensation in the treated area of the body.
Pharmaceutical analgesics may include a variety of classes of drugs, such as general anesthetics, non-steroidal anti-inflammatories, and local anesthetics. General anesthetics may reduce pain by producing a loss of consciousness. Local anesthetics may cause a loss of sensation in a localized area of the body without a loss of consciousness. Non-steroidal anti-inflammatories (NSAIDs) may ameliorate the pain but do not cause a loss of sensation or consciousness.
The NSAIDs such as piroxicam is generally administered orally, once or twice daily. NSAIDs may be less potent than the centrally acting narcotics and may have a different spectrum of side effects. The major adverse reactions of oral NSAIDs may include gastrointestinal tract ulceration, bleeding and perforation, blurred and/or diminished vision, edema, and prolonged bleeding time.
Accordingly, there is still a need for a composition and method to transdermally alleviate pain for an extended period of time, without the need for frequent administration of a drug, having a faster and more effective action to alleviate the pain caused by this inflammatory process.